Module 14: Design Development and Certification of Medical Devices

When should the Human Factors and Usability Engineering process be applied?

For most medical devices developers and manufacturers - compliance to International Regulations such as the European Medical Device Regulation (MDR) and the US-based FDA Design Controls Guidance (CFR Title 21, Section 820), and to country specific regulations (BS EN ISO 13485:2015) are the most common routes to ensure the development of a safe medical device. Human Factors and Usability Engineering is a front-end process. The first part of the process is User Research (Design Inputs). Verification and Validation activities often result in Formative and Summative Human Factors and Usability Studies and Tests which occur after design outputs.

Source: FDA Code of Federal Regulations, Title 21, Section 820.30 – Design Controls. The “Waterfall” design method.

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development